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A Tissue Collection Study of Pembrolizumab (MK-3475) in Subjects With Resectable Advanced Melanoma

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ClinicalTrials.gov Identifier: NCT02434354
Recruitment Status : Active, not recruiting
First Posted : May 5, 2015
Results First Posted : January 5, 2021
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Malignant Melanoma
Intervention Drug: pembrolizumab
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Neo-adjuvant/Adjuvant Pembrolizumab 200mgIV
Hide Arm/Group Description Pembrolizumab 200 mg: Subjects received 1 dose of neoadjuvant pembrolizumab, followed by complete resection, and then a year of adjuvant pembrolizumab.
Period Title: Overall Study
Started 33 [1]
Post Consent Screening 30
Completed 30
Not Completed 3
Reason Not Completed
screen fail             3
[1]
Consented
Arm/Group Title Neo-adjuvant/Adjuvant Pembrolizumab 200mg IV
Hide Arm/Group Description Pembrolizumab 200 mg: Subjects received 1 dose of neoadjuvant pembrolizumab, followed by complete resection, and then a year of adjuvant pembrolizumab.
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
Subjects who were consented and completed post-consent screening
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
17
  56.7%
>=65 years
13
  43.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
12
  40.0%
Male
18
  60.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
30
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
30
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
Stage at Study Entry   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants
Stage IIIB 12
Stage IIIC 17
Stage IV 1
[1]
Measure Description: Stage IIIB (at least 1 bulky regional lymph node), IIIC (bulky regional lymph nodes and/or ulcerated primary tumor), Stage IV (distant metastasis)
Baseline LDH  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants
Normal 30
Elevated 29
No Data 1
Primary Site  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants
cutaneous 24
unknown 6
BRAF V600  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants
Wild Type 9
Mutant 7
Unknown 14
Prior Therapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants
PLX4032 1
None 29
1.Primary Outcome
Title Number of Participants (%) With CTCAE Graded Adverse Events
Hide Description Safety as defined by 1) all grade 3/4 adverse events and 2) any grade adverse event that occurred in>5% of patients. Toxicities are graded using CTCAE Version 4.
Time Frame within 30 days of final study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Neo-adjuvant/Adjuvant Pembrolizaumab 200 mg IV
Hide Arm/Group Description:

All subjects will receive 1 cycle neo-adjuvant pembrolizumab 200mg IV followed by complete surgical resection followed by pembrolizumab Q3weeks for 1 year

pembrolizumab: 200 mg Subjects will receive 1 dose of neoadjuvant pembrolizumab, followed by complete resection and then a year of adjuvant pembrolizumab

Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
6
  20.0%
2.Secondary Outcome
Title Disease Free Survival
Hide Description To evaluate disease free survival (DFS) in patients receiving Pembrolizumab as adjuvant therapy
Time Frame until death, withdrawal of consent of end of the study. as such, we have not reached the median DFS and will report at the end of the study
Outcome Measure Data Not Reported
Time Frame 15 months
Adverse Event Reporting Description All SAEs are reported. Grade 3-5 AEs and SAEs and occurring in at least 5% of subjects are reported.
 
Arm/Group Title Neo-adjuvant/Adjuvant Pembrolizumab 200mg IV
Hide Arm/Group Description Pembrolizumab 200 mg: Subjects received 1 dose of neoadjuvant pembrolizumab, followed by complete resection, and then a year of adjuvant pembrolizumab.
All-Cause Mortality
Neo-adjuvant/Adjuvant Pembrolizumab 200mg IV
Affected / at Risk (%)
Total   6/30 (20.00%)    
Hide Serious Adverse Events
Neo-adjuvant/Adjuvant Pembrolizumab 200mg IV
Affected / at Risk (%) # Events
Total   6/30 (20.00%)    
Gastrointestinal disorders   
esophageal obstruction  [1]  1/30 (3.33%)  1
colitis  [1]  1/30 (3.33%)  1
Immune system disorders   
Anaphylaxis  [2]  1/30 (3.33%)  1
Enteritis  [3]  1/30 (3.33%)  1
Infections and infestations   
wound infection  [1]  1/30 (3.33%)  1
sepsis  [4]  1/30 (3.33%)  2
Indicates events were collected by systematic assessment
[1]
Grade 3 unrelated
[2]
Grade 3 possibly related
[3]
grade 3 enteritis possibly related
[4]
grade 4 unrelated
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Neo-adjuvant/Adjuvant Pembrolizumab 200mg IV
Affected / at Risk (%) # Events
Total   2/30 (6.67%)    
Skin and subcutaneous tissue disorders   
Rash  [1]  2/30 (6.67%)  3
Indicates events were collected by systematic assessment
[1]
Grade 3 rash
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Tara Mitchell
Organization: Abramson Cancer Center
Phone: 215-662-7908
EMail: tara.mitchell@pennmedicine.upenn.edu
Layout table for additonal information
Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02434354    
Other Study ID Numbers: UPCC 01615
First Submitted: April 30, 2015
First Posted: May 5, 2015
Results First Submitted: March 6, 2020
Results First Posted: January 5, 2021
Last Update Posted: January 5, 2021